Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Change in High-Sensitivity C-Reactive Protein (hs-CRP)
研究概览
简要总结
This pilot study aims to explore the potential benefits of consuming Greek bottarga (grey mullet fish roe) in individuals with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes.
Before initiating the crossover randomized controlled trial (RCT), the investigators will conduct a preliminary dose-testing study in five adults with at least one metabolic abnormality. Participants will undergo clinical assessments before and after the dietary intervention to evaluate changes in metabolic health markers. Following this phase, the investigators will proceed with a randomized, controlled crossover trial involving 20 eligible adult participants. This main study phase will compare the metabolic effects of daily bottarga supplementation with those of a calorically matched dairy product over an 8-week intervention period, with a 2-week washout period between interventions.
The investigators anticipate that bottarga supplementation will improve lipid profiles, inflammation markers, and insulin resistance, thereby supporting the potential use of sustainable blue foods as part of a healthy diet.
详细描述
Rationale/goals: Greek Bottarga (Grey mullet fish roe) is a traditional marine or "blue" food "that is produced in a sustainable manner. Bottarga's composition supports that it has excellent nutritional properties, but to date no human/clinical studies have been published. This pilot study will explore the potential benefits of Bottarga consumption in humans. If the results show potential benefits, this would help promote more sustainable blue foods. Methods: Before initiating the crossover randomized controlled trial (RCT), the investigators will conduct a preliminary dose-testing study in five adults with at least one metabolic abnormality, who will consume 20 g/day of Bottarga. Participants will undergo clinical assessments before and after the dietary intervention to evaluate changes in metabolic health markers.
The current randomized, controlled, cross-over pilot study (Open Label, Two-Arms) will investigate the metabolic effects of daily bottarga supplementation (versus a calorically equal dairy product) in 20 participants with at least one metabolic abnormality for 8 weeks with a 2-week "washout" period between food supplement arms. The primary outcome will be determined based on the most clinically important results observed during phase 1. Anticipated Results: The investigators expect Bottarga supplementation to be associated with more beneficial changes on lipid profiles, inflammatory markers and insulin resistance compared to baseline measures and to the calorically equivalent comparator food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-60 years
- •Residents of Massachusetts
- •Presence of at least one metabolic abnormality (low HDL cholesterol, elevated LDL cholesterol, elevated triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes
- •Not pregnant
- •Willing to consume a nutritional supplement and comply with study procedures
排除标准
- •Use of any medications for diabetes (except metformin), dyslipidemia (except statins), or immunosuppression
- •Current use of any supplements containing n-3 fatty acids
- •Current use of illicit drugs (other than marijuana)
- •Use of hormone therapy (except oral contraceptives)
- •Known allergies to fish, seafood, or any fish-derived products, including bottarga
- •Pregnancy
- •Clinical evidence or history of hepatic or renal insufficiency
- •Immunodeficiency conditions
- •History of non-skin cancer
- •Participation in other clinical research studies
研究组 & 干预措施
Bottarga supplementation (intervention group)
Ten participants with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes will be randomly allocated to 8 weeks of daily bottarga supplementation (20 grams/day; participants weighing >100 kg [220 lbs] will consume 40 g/day) as an initial treatment. Baseline assessment measures will be repeated, followed by a 2-week wash-out period. Then, assessment measures will be repeated followed by 8 weeks of daily cream cheese supplementation (28 grams/day; participants weighing >100 kg [220 lbs] will consume 56 g/day), followed by final assessment measures.
干预措施: Bottarga (Other)
Cream cheese supplementation (control)
Ten participants with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes will be randomly allocated to 8 weeks of daily cream cheese supplementation (28 g/day) as the initial intervention. Baseline assessment measures will be repeated, followed by a 2-week wash-out period. Then, assessment measures will be repeated, followed by 8 weeks of daily Bottarga supplementation (20 g/day;participants weighing >100 kg [220 lbs] will consume 40 g/day), followed by final assessment measures.
干预措施: Comparator (Other)
结局指标
主要结局
Mean Change in High-Sensitivity C-Reactive Protein (hs-CRP)
时间窗: From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).
Mean change in serum hs-CRP levels (mg/L) after overnight fast.
Mean Change in Hemoglobin A1c (HbA1c)
时间窗: From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).
Mean change in HbA1c levels (%) after overnight fast.
Mean change in fasting glucose
时间窗: From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).
Mean change in fasting glucose levels (mg/dL) after overnight fast.
Mean Change in Lipid Profile (Total Cholesterol, Triglycerides, HDL-C, LDL-C)
时间窗: From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).
Mean change in fasting lipid levels-including total cholesterol (mg/dL), triglycerides (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), and low-density lipoprotein cholesterol (LDL-C, mg/dL after overnight fast.
次要结局
- Mean change in resting blood pressure(From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).)
- Mean change in body mass index(From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).)
- Mean change in body fat(From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).)
- Mean change in waist circumference(From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).)
- Mean change in waist/hip ratio(From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).)
- Mean change in liver enzymes(From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).)